Analyzing children with congenital diarrhea and enteropathy in China
A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
This study is trying to find out more about children in China with congenital diarrhea and enteropathy by looking for signs of the condition and creating a database to help manage it better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 3 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06356545 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a clinical cohort of children suffering from congenital diarrhea and enteropathy (CODE) in China. Researchers will utilize multi-omics technology to identify biomarkers associated with CODE and develop a clinical phenotype database. Additionally, the study will employ artificial intelligence to construct a clinical risk prediction model to better understand and manage this condition.
Who should consider this trial
Good fit: Ideal candidates include children with chronic diarrhea lasting more than two months or over one month for those under two months of age, whose parents or legal guardians provide consent.
Not a fit: Patients with chronic diarrhea caused by specific infections or conditions such as necrotizing enterocolitis or short bowel syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for children with congenital diarrhea and enteropathy.
How similar studies have performed: While similar studies utilizing multi-omics approaches have shown promise in other conditions, this specific application in congenital diarrhea and enteropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age * Patients with consent from parents or legal guardians Exclusion Criteria: * Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile * Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome * Functional diarrhea * Patients with poor compliance
Where this trial is running
Shanghai, Shanghai Municipality
- Yanqiu Wang — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ying Huang, MD,PHD
- Email: yhuang815@163.com
- Phone: +862164931727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.